Cleared Traditional

AVI MODEL 870 DUAL CHANNEL INFUSION PUMP (K912031) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912031 · 3M Avi, Inc. · General Hospital
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Jun 1991
Decision
41d
Days
Class 2
Risk

K912031 is an FDA 510(k) clearance for the AVI MODEL 870 DUAL CHANNEL INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by 3M Avi, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 18, 1991 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Avi, Inc. devices

Submission Details

510(k) Number K912031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1991
Decision Date June 18, 1991
Days to Decision 41 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 129d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 232
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K912031.
EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT
K905778 · Baxter Healthcare Corp · Jul 1991
BARD ALFENTANIL INFUSER
K904890 · C.R. Bard, Inc. · Jun 1991
FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM
K910934 · Baxter Healthcare Corp · Jun 1991
VOLUMETRIC INFUSION PUMP
K910024 · Baxter Healthcare Corp · May 1991
ABBOTT LIFECARE 5000 PUMP
K911401 · Abbott Laboratories · May 1991
ABBOTT LIFECARE 5000 PUMP MODIFIED
K910919 · Abbott Laboratories · May 1991